MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH LACTATE_2 (LAC_2)

Model Number	ATELLICA CH LACTATE_2 (LAC_2)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) for lactate_2 recovered in range the morning on (b)(6) 2021 but recovered out of range on (b)(6) 2021.There were no issues with other assays.The customer confirmed that the operator was not trained on proper handling of lac_2 reagent.The operator did not prepare the lac_2 reagent in accordance with the assay instructions for use (ifu).After replacing the onboard lac_2 reagent with lac_2 reagent that was correctly prepared per the ifu instructions, qc recovered in range and no further issues were observed with patient results.The cause of the event was use error due to improper reagent handling.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 2432235-2022-00016 was filed for the discordant lac_2 results obtained on (b)(6) 2021.
Event or Problem Description
Discordant, falsely low lactate_2 (lac_2) results were obtained on patient samples over a two day period on an atellica ch 930 analyzer using atellica ch lactate_2 (lac_2) reagent.The discordant results were reported to the physician(s) and were questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant lac_2 results.

• Brand Name: ATELLICA CH LACTATE_2 (LAC_2)
• Common Device Name: ATELLICA CH LACTATE_2 (LAC_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 13228833
• Report Number: 2432235-2022-00015
• Device Sequence Number: 4313287
• Product Code: KHP
• UDI-Device Identifier: 00630414287270
• UDI-Public: 00630414287270
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: ATELLICA CH LACTATE_2 (LAC_2)
• Device Catalogue Number: 11532568
• Device Lot Number: 211376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown